Comparison of a Fixed-Schedule Therapy Versus a Symptom-Triggered Therapy for Alcohol Withdrawal Syndrome in Medical Out-Patients
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Hvidovre University Hospital
- Enrollment
- 165
- Locations
- 1
- Primary Endpoint
- Patient satisfaction
Study Overview
Brief Summary
The purpose of this study is to compare a fixed-schedule therapy versus a symptom-triggered therapy for alcohol withdrawal syndrome in medical outpatients.
Objectives:
- Self-governance in monitoring AWS (alcohol withdrawal syndrome) symptoms and medication
- Clinically controlled trial of two regimens for medical treatment of alcohol withdrawal syndrome
- Outpatient treatment of alcohol withdrawal syndrome
Detailed Description
The objective of this study is to compare a fixed-schedule therapy versus a symptom-triggered therapy for alcohol withdrawal syndrome in medical outpatients.
Objectives:
- Self-governance in monitoring AWS (alcohol withdrawal syndrome) symptoms and medication
- Clinically controlled trial of two regimens for medical treatment of alcohol withdrawal syndrome
- Outpatient treatment of alcohol withdrawal syndrome
Patients and Methods:
This study is a prospective analysis of patients admitted to a medical outpatient clinic between August 25, 2003 and July 1, 2006, who experienced AWS. This study is conducted at Copenhagen Hospital Corporation in Copenhagen, Denmark. Patients were divided into two randomized groups: a symptom-triggered treatment versus a fixed-schedule treatment (known) with chlordiazepoxide. They were diagnosed with AWS according to DSM-IV (Diagnostic and Statistical Manual of Mental Disorders Fourth Edition). They were diagnosed with alcohol dependence according to the ICD-10 (International Statistical Classification of Diseases and Health Related Problems).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients above the age of 18
- •Fulfilled informed consent
- •Abstained from alcohol within the last 72 hours.
- •Agree on both treatment regimens.
- •Abstinence during 10 days (monitoring and medication period), i.e. treatment with disulfiram or oral alcometer test on every attendance (Lion Alcometer S-D2).
Exclusion Criteria
- •Oral alcoholmeter test > 0.
- •Treatment of AWS within the last week
- •3 earlier attempts at outpatient detoxification within the last 2 months without success.
- •Allergy or adverse reactions to chlordiazepoxide
- •Treatment with medication in interaction with chlordiazepoxide
- •Psychiatric comorbidity within the last year, dependence on other drugs except nicotine dependence
- •Medically severe comorbidity, especially severe liver insufficiency
- •Severe cardiovascular diseases, NIDDM and IDDM.
- •A history within the last year of seizures and delirium tremens.
- •Patients should be cooperative in terms of cooperation and understanding of the Danish language.
- •Females of fertile age without safe contraception, (i.e. IUD, hormone tablets or sterilisation) also pregnant or breastfeeding women were excluded.
Outcomes
Primary Outcomes
Patient satisfaction
To give the most safe treatment to the patients and reduce the risk of further development of alcohol withdrawal syndrome with seizures and delirium tremens
To shorten the AWS-period by determining the time to Short Alcohol Withdrawal Scale (SAWS)-score is below 12
Use of medication
AWS score day 1, 2, 3, etc.
Wellbeing
Secondary Outcomes
- Compliance in alcohol treatment
- Time to first relapse